Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496392
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : May 7, 2012
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Brief Summary:


• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.


  • To compare patients' general impression and preference of NF and Actiq
  • To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid
  • To assess safety and tolerability of NF

Condition or disease Intervention/treatment Phase
Pain Drug: Nasal fentanyl Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer
Study Start Date : January 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Nasal fentanyl
    Breakthrough pain in patients with breast or prostate cancer
    Other Name: Instanyl

Primary Outcome Measures :
  1. Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. • Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.
  • Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.
  • Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.
  • Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.
  • Previous use of Actiq is accepted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00496392

Roskilde, Denmark, 4000
Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquaters

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nycomed Identifier: NCT00496392     History of Changes
Other Study ID Numbers: FT-019-IM
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Nycomed:
breakthrough pain in patients with cancer

Additional relevant MeSH terms:
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General